The CGCI Systcm received product certification from Underwriters Laboratories (UL). Underwriters Laboratories is a trusted organization around the globe for product safety certification and compliance. “Our rapid and efficient UL certification of CGCI validates the outstanding work of the engineering and technical team in creating a safe and highly reliable new technology for magnetically guided robotic surgery,” said Josh Shachar, Chief Innovation Officer of Neuro-Kinesis. “This is an important step in the preparation of upcoming CGCI installations for human trials and pre-commercialization applications in Europe and the US. At the same time, we are currently making concrete preparations to establish the company’s CGCI systems in leading hospitals in Europe, the US, and Asia.”
CGCI uses eight electromagnets in a unique configuration to intelligently guide a magnetically-tipped catheter, enabling a physician to precisely and consistently control surgical tools in highly dynamic or previously inaccessible environments while enhancing both the physician’s dexterity and patient’s safety. The platform has received USDA certification of its electrophysiology surgical suites and is currently preparing for Good Laboratory Practice certification at the company’s facilities in Los Angeles.
The first installation of the CGCI surgical suite system for human trials will be at a leading EP center located at Hospital Universitario La Paz in Madrid, under the auspices of Dr. Vivek Reddy, Director of the Electrophysiology at the Mount Sinai Medical Center in New York City, and Dr. Jose Luis Merino Llorens, Director of the Arrhythmia & Electrophysiology Research Unit at Hospital General Universitario La Paz. These trials will initially study the CGCI system in the mapping of the heart a diagnostic procedure that is performed for patients who have arrhythmia, or irregular heartbeat. These trails will provide validation for the system as both a CE Mark and FDA 510(k) certification is applied for mapping and then for approval of the system for a therapeutic procedure known as ablation that is used to correct heart arrhythmia.